510(k) · Cleared
ClearedProxeo ULTRA (PB-510, PB-520 and PB-530)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoss GmbH · ELC Scaler, Ultrasonic
Cleared on Jul 14, 2023 as substantially equivalent to K140965 (Mectron S.P.A., 2014) after a 276-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Jul 14, 2023
- Review
- 276 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896749 (1990). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- 6 generations backK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- 5 generations backK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
- 4 generations backK052518 PiezosurgeryPiezosurgery S.R.L. · 2005
- 3 generations backK091227 Piezosurgery 3; Osstem PiezoPiezosurgery S.R.L. · 2009
- 2 generations backK102218 Compact Piezo P2K, PowercareMectron S.P.A. · 2011
- 1 generation backK140965 Multipiezo Pro, MultipiezoMectron S.P.A. · 2014
- This deviceK223173 Proxeo ULTRA (PB-510, PB-520 and PB-530)W&H Dentalwerk Buermoss GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| −6 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| −5 | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
| −4 | K052518 | Piezosurgery | Piezosurgery S.R.L. | 2005 | — |
| −3 | K091227 | Piezosurgery 3; Osstem Piezo | Piezosurgery S.R.L. | 2009 | — |
| −2 | K102218 | Compact Piezo P2K, Powercare | Mectron S.P.A. | 2011 | — |
| −1 | K140965 | Multipiezo Pro, Multipiezo | Mectron S.P.A. | 2014 | — |
| 0 (this device) | K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ELC device
- #1 K260773 Varios Combi Pro2score 12.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K140965.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · ELC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELC
104in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELC
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELC
284in 2025
MAUDE reports naming product code ELC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 92 | 0 | 12 |
| 2008 | 4 | 216 | 0 | 58 |
| 2009 | 4 | 121 | 0 | 108 |
| 2010 | 4 | 201 | 0 | 79 |
| 2011 | 3 | 122 | 0 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 13 | 174 | 0 | 6 |
| 2014 | 6 | 193 | 0 | 37 |
| 2015 | 5 | 150 | 0 | 135 |
| 2016 | 3 | 88 | 0 | 169 |
| 2017 | 2 | — | 0 | 356 |
| 2018 | 1 | — | 0 | 289 |
| 2019 | 4 | 192 | 0 | 302 |
| 2020 | 1 | — | 0 | 164 |
| 2021 | 3 | 196 | 0 | 166 |
| 2022 | 2 | — | 2 | 165 |
| 2023 | 5 | 258 | 0 | 210 |
| 2024 | 4 | 104 | 0 | 219 |
| 2025 | 2 | — | 0 | 284 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation.
The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223173: Proxeo ULTRA (PB-510, PB-520 and PB-530).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223173
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026